1. Field of the Invention
This invention pertains generally to a method and apparatus for in vitro and in vivo therapeutic and prophylactic treatment of plant, animal, and human molecules, cells, tissues, organs, portions of entire organisms and entire organisms. In particular, an embodiment according to the present invention pertains to use of non-thermal static and time-varying electromagnetic fields configured to accelerate the asymmetrical kinetics of the binding of intracellular ions to their respective buffers which regulate the biochemical signaling pathways living systems employ for growth, repair and maintenance. Another embodiment according to the present invention pertains to the non-thermal application of repetitive pulse bursts of sinusoidal, rectangular, chaotic or arbitrary waveform electromagnetic fields to instantaneously accelerate ion-buffer binding in signaling pathways in structures such as molecules, cells, tissues, organs, and entire organisms of plants, animals or humans using ultra lightweight portable coupling devices such as inductors and electrodes, driven by miniature signal generator circuitry that can be incorporated into an anatomical positioning device such as a dressing, bandage, compression bandage, compression dressing; knee, elbow, lumbar or cervical back, shoulder, foot, head, neck and other body portion wraps and supports; garments, footwear, gloves, and fashion accessories; mattress pads, seat cushions, beds, furniture; seats, beds, cushions and other body supports in cars, motorcycles, bicycles, buses, trains, airplanes, boats and ships.
Yet another embodiment according to the present invention pertains to application of sinusoidal, rectangular, chaotic or arbitrary waveform electromagnetic signals, having frequency components below about 100 GHz, configured to accelerate the binding of intracellular Ca2+ to a buffer, such as calmodulin (hereinafter known as CaM), to enhance biochemical signaling pathways in target structures such as plant, animal and human molecules, cells, tissues, organs, portions of entire organisms and entire organisms. Signals configured according to embodiments of the present invention produce a net increase in abound ion, such as Ca2+ at CaM binding sites because the asymmetrical kinetics of Ca/CaM binding allows such signals to accumulate voltage induced at the ion binding site, thereby accelerating voltage-dependent ion binding. Examples of therapeutic and prophylactic applications of the present invention are modulation of biochemical signaling in anti-inflammatory pathways, modulation of biochemical signaling in cytokine release pathways, modulation of biochemical signaling in growth factor release pathways; chronic and acute musculoskeletal pain relief; edema and lymph reduction, anti-inflammatory, post-surgical and post-operative pain and edema relief, nerve, bone and organ pain relief, angina pain relief, increased local blood flow, microvascular blood perfusion, treatment of tissue and organ ischemia, cardiac tissue ischemia, brain tissue ischemia from stroke or traumatic brain injury, treatment of neurological injury and neurodegenerative diseases such as Alzheimer's and Parkinson's; wound repair, bone repair, tissue repair; osteoporosis treatment and prevention; degenerative bone disease treatment and prevention; angiogenesis, neovascularization; enhanced immune response; treatment of diabetes Types I and II; enhanced effectiveness of pharmacological agents; nerve regeneration, skeletal muscle regeneration, cardiac muscle regeneration; cancer treatment; prevention of apoptosis; modulation of heat shock proteins for prophylaxis and response to injury or pathology. An embodiment according to the present invention can also be used in conjunction with other therapeutic and prophylactic procedures and modalities such as heat, cold, light, ultrasound, mechanical manipulation, massage, physical therapy, vacuum assisted wound closure, wound dressings, orthopedic and other surgical fixation devices, and surgical interventions. Yet another embodiment according to the present invention can also be used in conjunction with all pharmacological agents. Another embodiment of the present invention can be used with imaging or non-imaging diagnostic procedures.
2. Discussion of Related Art
Bone growth stimulator (hereinafter known as BGS) electromagnetic fields are now part of the standard armamentarium of orthopedic practice worldwide for the treatment of recalcitrant bone fractures. Radio frequency signals, originally developed for deep tissue heating (diathermy), were shown to produce biological effects when applied at non-thermal levels using pulse-modulation techniques to produce pulsed radio frequency (hereinafter known as PRF) signals. At the cellular level, numerous studies demonstrate that BGS, PRF and other electromagnetic field (hereinafter known as EMF) signals modulate the release of growth factors and cytokines.
Stimulation of transforming growth factor beta (“TGF-β”) messenger RNA (“mRNA”) with EMF in a bone induction model in a rat has been shown. Studies have also demonstrated up regulation of TGF-β mRNA by PEMF in human osteoblast-like cell line designated MG-63, wherein there were increases in TGF-β1, collagen, and osteocalcin synthesis. EMF stimulated an increase in TGF-β1 in both hypertrophic and atrophic cells from human non-union tissue. Further studies demonstrated an increase in both TGF-β1 mRNA and protein in osteoblast cultures resulting from a direct effect of EMF on a calcium/calmodulin-dependent pathway. Cartilage cell studies have shown similar increases in TGF-β1 mRNA and protein synthesis from EMF, demonstrating a therapeutic application to joint repair. U.S. Pat. No. 4,315,503 (1982) to Ryaby, U.S. Pat. No. 7,468,264 (2008) to Brighton and U.S. Pat. No. 5,723,001 (1998) and U.S. Pat. No. 7,744,524 (2010) to Pala typify the research conducted in this field.
However, prior art in this field has not produced electromagnetic signals configured specifically to accelerate the asymmetrical kinetics of the binding of intracellular ions to their associated buffers which regulate the biochemical signaling pathways living systems employ for growth, repair and maintenance. The result is that application of prior art devices, such as BGS devices and PRF devices, requires excessively long treatment times with associated prolonged patient morbidity, equivocal outcomes, and unnecessarily higher health care expenses.
Therefore, a need exists for an apparatus and a method that more effectively modulates the biochemical pathways that regulate tissue growth, repair and maintenance by configuring EMF signals specifically to accelerate the asymmetrical kinetics of ion binding to intracellular buffers which regulate the biochemical signaling pathways living systems employ for growth, repair and maintenance. A method based upon the current invention will be more effective by shortening treatment times, producing enhanced outcomes, reducing morbidity and reducing the cost of health care. An apparatus based upon the current invention incorporates miniaturized circuitry and light weight coil applicators or electrodes thus allowing the apparatus to be low cost, portable and, if desired, disposable. A further need exists for an apparatus and method that incorporates the asymmetrical kinetics of ion binding to intracellular buffers to configure electromagnetic waveforms to increase the rate of ion binding and enhance the biochemical signaling pathways living systems employ for growth, repair and maintenance. This shortens treatment times, produces enhanced outcomes, reduces morbidity and the cost of health care, and incorporates miniaturized circuitry and light weight applicators that can be constructed to be implantable.